Topical administration of Oftaquix® and Tobrex® in refractive surgery

Abstract

Background: Due to the growing resistance of causative microorganisms to previous generations of antibiotics and to the risk of post-op infectious complications associated with it, an efficacy and safety assessment of modern fluoroquinolones’ prophylactic topical administration appears to be reasonable. Purpose: To investigate the efficacy and safety of levofloxacin 0.5 % ophthalmic solution (Oftaquix®, Santen, Finland) topical use in modern excimer laser refractive surgery (LASIK). Material and methods: Patients were randomized into two treatment groups: Thirty two patients (64 eyes) were treated with levofloxacin 0.5 % ophthalmic solution (Oftaquix®, Santen, Finland) b.i.d. and thirty patients (60 eyes) received tobramycine 0.3 % eye drops (Tobrex®, Alcon-Couvreur, Belgium) q. t.d., both during first 7 days post-op. LASIK procedure using excimer laser MEL-80 (Carl Zeiss Meditec, Germany) and mechanical microkeratome LSK Moria Evolution-2 (Moria, France) was performed in all patients for myopia from –1.0 to –12.0 D. Patient’s age varied from 18 to 40 years (mean age 28.4±7.8). Results: During topical application of Oftaquix® and Tobrex® in our refractive surgery patients there were no topical, or systemic adverse reactions, or allergic reactions. Oftaquix® and Tobrex® had good topical tolerability. Therapeutic dosage regimen, sufficient in terms of anti-infective prophylaxis, in case of Oftaquix® was twice as low in comparison to Tobrex®. Tear film break-up time (TFBUT) preand post-op was comparable between groups. In both groups, TFBUT post-op was significantly lower compared to pre-op values (p 0.01). Tear production (Shirmer-I test) in both groups remained almost the same (p 0.05). Conclusion: Oftaquix® (Santen, Finland) ophthalmic solution is effective and safe for prevention of infectious complications after LASIK and appears to be a rational alternative to tobramycine 0.3 % eye drops (Tobrex®, Alcon-Couvreur, Belgium).